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临床试验/NCT03692286
NCT03692286已完成4 期

Assessment of Postoperative Pain After Using Silver Nanoparticles With and Without Calcium Hydroxide as an Intracanal Medication in Patients With Necrotic Pulp: (A Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in post-operative pain

研究概览

简要总结

To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)

详细描述

When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
  • Non-pregnant females
  • Asymptomatic necrotic mandibular single rooted teeth.
  • Normal occlusal contact with the opposing teeth.
  • Patients accepting to participate in the study.

排除标准

  • Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
  • Pregnant women: Avoid radiation exposure, anesthesia, and medication.
  • If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception
  • Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows:
  • Association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
  • Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
  • No restorability: Hopeless tooth.
  • Vital teeth
  • Immature teeth
  • Radiographic evidence of external or internal root resorption.
  • Any criterion, not mentioned in the inclusion criteria

研究组 & 干预措施

AgNP

Active Comparator

Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping

干预措施: Silver Nanoparticles in gel form (Drug)

Ca(OH)

Active Comparator

Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping

干预措施: Calcium Hydroxide Intracanal medication (Drug)

AgNP/Ca(OH)

Active Comparator

Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping

干预措施: Silver nanoparticle/Calcium hydroxide (Combination Product)

结局指标

主要结局

Change in post-operative pain

时间窗: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours

Numerical (0-10)

次要结局

  • Intracanal Bacterial count reduction(1 week)
  • Number of analgesic tablets taken by the patient after endodontic treatment(Within 4 days after the first session and after 1 week from first treatment session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nermine Elsayed Abdelsalam Hassan

Assistant Lecturer of Endodontics

Cairo University

研究点 (1)

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